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This is a Phase 3, multicenter, randomized, double-blind, safety and efficacy study of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO) administered for a total of 14 to 28 days in adult subjects with moderate or severe DFI.
Approximately 865 subjects (519 contezolid acefosamil/contezolid: 346 linezolid) will be enrolled with moderate or severe DFI that are confirmed or suspected to be due to a Gram-positive bacterial pathogen (MITT analysis set).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| contezolid acefosamil/contezolid | Experimental |
| |
| linezolid | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| contezolid acefosamil (IV)/contezolid (PO) | Drug | Contezolid acefosamil (IV)/contezolid (PO) administered for a total of 14 to 28 days (28 to 56 doses) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators | The primary objective is to evaluate the Investigator's assessment of clinical response at the D35 visit in subjects receiving contezolid acefosamil/contezolid compared to subjects receiving linezolid in the MITT analysis | Day 35 |
| Adverse events - symptoms reported by subjects | Evaluate safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO) | 28-35 days after End-of-Therapy (EOT) |
| Clinical laboratory assessment - complete blood count | Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO) | 28-35 days after End-of-Therapy (EOT) |
| Vital signs - heart rate | Will be evaluated under safety of contezolid acefosamil (IV)/contezolid (PO) compared with linezolid (IV and PO) | 28-35 days after End-of-Therapy (EOT) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators | Evaluate the Investigator's assessment of clinical response at EOT visit in the MITT analysis set | 14-28 days |
| Clinical response calculated with percentage of subjects with resolution of DFI signs and symptoms and requiring no further therapy as assessed by Investigators |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical coordinator | Contact | 510-782-2022 | info@micurx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Hope Research Development | Recruiting | Corona | California | 92882 | United States | |
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| Linezolid (IV and PO) | Drug | Linezolid (IV and PO) administered for a total of 14 to 28 days (28 to 56 doses) |
|
Evaluate the Investigator's assessment of clinical response at Day 10 (D10) and Late Follow-Up visits (LFU; 28-35 days after EOT) in the MITT analysis set |
| Day 10, 28-35 days after EOT |
| ILD Research Center |
| Recruiting |
| Vista |
| California |
| 92081 |
| United States |
| MHAT Sveti Nikolay Chudotvorets EOOD | Recruiting | Lom | Bulgaria |
| Multiprofile Hospital for Active Treatment - KANEV | Recruiting | Rousse | Bulgaria |
| Medical Institute Ministry of Interior Central Clinical Base | Recruiting | Sofia | Bulgaria |
| University Multidisciplinary Hospital for Active Treatment and Emergency Medicine 'N. I. Priogov´ | Recruiting | Sofia | Bulgaria |
| South-Estonian Hospital Ltd. | Recruiting | Võru | Estonia |
| LTD High Technology Hospital Med Center | Recruiting | Batumi | Georgia |
| JSC Vian - West Georgia Medical Center | Recruiting | Kutaisi | Georgia |
| GMV Care& Research - Maria Cecilia Hospital | Recruiting | Cotignola | Italy |
| Daugavpils Regional Hospital | Recruiting | Daugavpils | Latvia |
| Instytut Medycyny Wsi im. W. Chodzki | Recruiting | Lublin | Poland |
| PODEMA Sp. z o.o. | Recruiting | Warsaw | Poland |
| University Clinical Center Kragujevac | Recruiting | Kragujevac | Serbia |
| ID | Term |
|---|---|
| D000069349 | Linezolid |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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